A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

A Phase IV Clinical Trial to Evaluate the Preventive Effectiveness of NSAID-Associated Gastroduodenal Injury (Multi-center, Double-blind, Active-controlled, Stratified Randomized, Parallel Group)

This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

Study Overview

• Status: Completed
• Conditions: NSAID-associated Gastroduodenal Injury
• Intervention / Treatment: Drug: Stillen; Drug: NSAID (Aceclofenac); Drug: Cytotec (reference drug)

Detailed Description

After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.

Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 614735
    • Inje University Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Need to take NSAID pills for longer than four weeks
• should be normal diagnosed by the endoscopy test

Exclusion Criteria:

• The patients have gastric ulcer or duodenal ulcer within 30 days
• The patients have a gastro-intestinal surgery within a year
• The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stillen; Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID	Drug: Stillen; Drug: NSAID (Aceclofenac)
ACTIVE_COMPARATOR: Cytotec; The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID	Drug: NSAID (Aceclofenac); Drug: Cytotec (reference drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of protected subjects (%)	the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A percentage of a protected subject (at duodenum), and of ulcer occurrence	The definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at duodenum by the endoscopy.; A percentage of ulcer occurrence	4 weeks

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Study Chair: Sang-Yong Seol, MD, Inje University; Principal Investigator: Myoung-Gyu Choi, MD, The Catholic University of Korea; Principal Investigator: Oh Young Lee, MD, Hanyang University; Principal Investigator: Dong Ho Lee, MD, Seoul National University Bundang Hospital; Principal Investigator: Yong Chan Lee, MD, Severance Hospital; Principal Investigator: Suck Chei Choi, MD, Wonkwang University School of Medicine & Hospital; Principal Investigator: Jong Sun Rew, MD, Chonnam National University Hospital; Principal Investigator: Kang Moon Lee, Saint Vincent's Hospital, Korea; Principal Investigator: Jae Young Jang, MD, KyungHee University Medical Center; Principal Investigator: Hoon-jai Chun, MD, Korea University Anam Hospital; Principal Investigator: Sang-woo Lee, MD, Korea University Ansan Hospital; Principal Investigator: Moo In Park, MD, Kosin University Gospel Hospital; Principal Investigator: Joong Goo Kwon, MD, Daegu Catholic University Medical Center; Principal Investigator: Geunam Song, MD, Pusan National University Hospital; Principal Investigator: Seong Woo Jeon, MD, Kyungpook National University Medical Center; Principal Investigator: Soo Taek Lee, MD, Chonbuk National University Hospital; Principal Investigator: Jae Gyu Kim, MD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Principal Investigator: Poong-Lyul Rhee, MD, Samsung Medical Center; Principal Investigator: Kwang Jae Lee, MD, Ajou University School of Medicine; Principal Investigator: Hyo Jin Park, MD, Gangnam Severance Hospital; Principal Investigator: Byung Ik Jang, MD, Yeungnam University Hospital; Principal Investigator: Yong Woon Shin, MD, Inha University Hospital; Principal Investigator: Dong Soo Han, MD, Hanyang University; Principal Investigator: Sung Kook Kim, MD, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (ESTIMATE): July 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Aceclofenac
• Other Study ID Numbers: DA9601_PG_IV